Dec. 17 Quick Takes: Ipsen, Genfit advancing former NASH candidate in PBC

A year and a half after PPARα and PPARδ agonist elafibranor missed the primary endpoint in a Phase III study to treat non-alcoholic steatohepatitis, Genfit S.A. (Euronext:GNFT; NASDAQ:GNFT) has chosen Ipsen Group (Euronext:IPN; Pink:IPSEY) as its partner to advance the program to treat primary biliary cholangitis. Ahead of top-line data due in 1Q23 from the Phase III ELATIVE trial in PBC, Ipsen paid €120 million for a global license to the product and acquired an 8% stake in Genfit for €28 million; Genfit is eligible for a further €360 million in milestones, plus royalties. The treatment has breakthrough therapy designation from FDA, and orphan drug designation in the U.S. and EU.

Pfizer Inc. (NYSE:PFE) and BioNTech SE (NASDAQ:BNTX) submitted an sBLA for their Comirnaty vaccine in adolescents aged 12-15 years. FDA authorized the emergency use of Comirnaty in this patient population on May 10. ...